Electrocardiographic safety of daily Hydroxychloroquine 400mg plus Azithromycin 250mg as an ambulatory treatment for COVID-19 patients in Cameroon.

Source: medRxiv

Abstract

Objective: To determine the early electrocardiographic changes in a cohort of ambulatory cameroonian COVID-19 patients treated with hydroxychloroquine and Azithromycin.

Design: Prospective study.

Setting: Treatment centres of the city of Yaounde, Cameroon, from May 7th to 24th 2020.

Participants: We enrolled 51 consecutive confirmed COVID-19 on RT-PCR who having mild forms of COVID-19 and treated by hydroxychloroquine 200mg twice daily during seven days plus Azithromycin 500 mg the first day and 250 mg the remaining 4 days as per national standard.

Main outcomes measures: The primary end-point was the change in QTc interval between day 0 (D0), day 3 (D3) and day 7 (D7). Secondary endpoints were changes in all other cardiac electrical conductivity patterns and the occurrence of clinical arrhythmic events during the course of treatment.

Results: The population (29 men and 22 women) was aged 39 +/- 11 years (range 17 to 61 years). Mean Tisdale score was 3.35 +/- 0.48. No significant change from baseline (D0) of QTc was observed at D7 (429 +/- 27 ms at D0 versus 396 +/- 26 ms at D7; p = 0.27). A reduction of heart rate was observed between the D0 and D7 (75 +/- 13 bpm versus 70 +/- 13 bpm, p = 0.02) with increased QRS duration between D0 and D7 (95 +/- 10 ms versus 102 +/- 17 ms, p = 0.004). No symptomatic arrhythmic events occurred during the treatment course.

Conclusions:

No life-threatening modifications of the QT interval was observed in non-severe COVID-19 patients treated ambulatory with hydroxychloroquine and azithromycin. Studies are needed in critical-ill and older patients.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

No funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the National Committee for Research Ethics in Human Health, Cameroon (Number 2020/05/1505/L/CNERSH/SP).

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

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